A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy with DBV712 250 µg in 1-through 3-year-old Children with Peanut Allergy

Peanut allergy

The following study drug safety criteria will be evaluated: • AEs and Treatment Emergent Adverse Events (TEAEs) by system organ class (SOC) and Preferred Term (PT), TEAEs by maximum severity, duration, and relatedness to treatment, TEAEs leading to discontinuation, Severity of local cutaneous DBV712 system induced AEs as assessed by the Investigator at study visits, AESI including local and systemic AESIs, Local AESIs: severe local site reactions (grade 4 with loss of skin barrier integrity), Systemic AESIs: systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to DBV712 250 µg, AEs leading to epinephrine use, irrespective of the causal relationship to DBV712 250 µg, AEs leading to inhaled or systemic corticosteroid use, irrespective of the causal relationship to DBV712 250 µg, SAEs by SOC and PTs and SAEs relatedness to treatment, Laboratory data, physical examinations and vital signs, Assessment of pain and ease of removal of DBV712

The following exploratory assessments will be evaluated: • Change from baseline in peanut-specific IgE and IgG4, Change from baseline in peanut-component-specific IgE and IgG4, Change from baseline in peanut SPT mean wheal diameters, Description of reactions triggered by peanut consumption during the study, SCORAD evolution over time, Assessment of system adhesion and average daily application time, Parent/caregiver daily assessment of Local Skin Reactions (itching, redness and swelling)

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